Not yet recruitingEARLY_PHASE1INTERVENTIONAL

Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain

This study is looking at how well two different types of injections work for pain in the sacroiliac joint, which is in your lower back. One type is a steroid injection, which is often used but can sometimes cause joint damage over time. The other type is a medicine called ketorolac, which is an anti-inflammatory drug. Researchers want to find out if ketorolac injections can relieve pain just as effectively as steroid injections, but without the risk of long-term damage to the joint. If ketorolac works well, it could mean a new, safer, and potentially cheaper way to manage SI joint pain for many people.

At a glance

Status

Not yet recruiting

Phase

EARLY_PHASE1

Sponsor

McMaster University

Enrolment target

Start

01 Jan 2025

Estimated completion

01 Jun 2026

Sacro-iliac Joint Pain

What is this study about?

Many people experience lower back pain, and a significant portion of that pain comes from a joint called the sacroiliac (SI) joint. This pain can happen when there's inflammation, or swelling, in the joint. Usually, doctors try things like exercise, physiotherapy, and medicines first. If these don't help enough, an injection into the SI joint might be considered.

The standard injection often uses a steroid medicine. While steroids are good at reducing pain by calming down inflammation, using them repeatedly can sometimes lead to damage to the joint over time. Because of this, doctors try to space out steroid injections as much as possible, even if your pain returns.

This study is exploring an alternative medicine called ketorolac. Ketorolac is a type of anti-inflammatory medicine, similar to ibuprofen, but in an injection form. Studies have shown that ketorolac injections can work just as well as steroids for pain in other joints like the shoulder or knee. The main goal of this study is to see if ketorolac injections can provide the same pain relief for SI joint pain as steroid injections, but without the potential for damaging the joint. If successful, this could mean you could have injections more often if needed, and it might also be a more affordable treatment.

Key takeaways

This study compares two different injections for lower back pain from the SI joint.
It aims to see if ketorolac is as good as steroids but safer for your joints in the long run.
Participation involves one ultrasound-guided injection and follow-up at 2, 6, and 12 weeks.
People with long-term SI joint pain (over 3 months) might be eligible.
This research hopes to find a new, effective, and possibly cheaper treatment option.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or over. You must have been experiencing pain in your SI joint for at least three months. Also, during a physical examination, your doctor would need to find at least three specific signs that suggest your pain is coming from your SI joint.

There are also some reasons why you wouldn't be able to join. For example, if you've had back surgery before, or if your pain is coming from other issues like trapped nerves in your leg, disc problems in your back, or muscle pain. If you have depression, certain infections, or a condition that affects your thinking and makes it hard to understand the study, you wouldn't be able to take part.

Lastly, if you're allergic to any of the medicines used in the study, or if you have certain health conditions that mean you shouldn't take anti-inflammatory drugs like ketorolac (such as stomach bleeds, kidney failure, severe heart failure, or liver disease), you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had SI joint pain for at least three months?
Has your doctor found specific signs of SI joint pain during an exam?
Have you NOT had previous back surgery?
Do you NOT have stomach ulcers, kidney problems, or severe heart/liver issues?
Are you NOT allergic to any medicines similar to ibuprofen?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive an injection directly into your sacroiliac joint. This injection would be guided by ultrasound to ensure it's in the correct place. You might receive either the steroid medicine or the ketorolac medicine; which one you get would be decided by chance, like flipping a coin. After the injection, the study team would follow up with you at 2, 6, and 12 weeks to see how your pain is progressing. The total duration of your participation in the study would be about 3 months.

Potential risks and benefits

Taking part in this study could potentially offer you pain relief from your SI joint pain, and if ketorolac is effective, it might provide a treatment option with fewer long-term risks to your joint compared to traditional steroid injections. However, as with any injection, there's always a small risk of discomfort, bruising, or infection at the injection site. There are also known side effects associated with anti-inflammatory drugs like ketorolac, though injecting them directly into a joint may reduce some of the whole-body effects. You are free to withdraw from the study at any time without giving a reason, and your decision will not affect your future medical care.

Locations (1)

Michael G. DeGroote Pain Clinic
Verified postcode
Hamilton, Canada

Common questions

What is the sacroiliac (SI) joint?

It's a joint in your lower back, connecting your spine to your pelvis. Pain here can cause discomfort in your lower back, buttocks, and sometimes your legs.

What's the difference between steroid and ketorolac injections?

Steroid injections are common for pain relief but can damage joints with repeated use. Ketorolac is an anti-inflammatory medicine that might offer similar relief without that joint damage.

Will I know which medicine I'm getting?

No, you will be assigned to either the steroid or ketorolac group randomly, and neither you nor the researchers will know which one you receive until after the study is complete. This helps ensure fair results.

How long will the study last for me?

Your involvement in the study will last for about 12 weeks after your injection, with follow-up checks at 2, 6, and 12 weeks.

Can I still get other treatments for my pain during the study?

The study team will discuss this with you, as certain treatments might interfere with the study results. It's important to tell them about all your current and planned treatments.

How to find out more

Akil Siva, MD

akilsiva001@gmail.com 905-521-2100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.